• Title/Summary/Keyword: Certification & Level System

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The Impact of ISO 13485 on the Performance of Korean Medical Device Manufacturers (ISO 13485 인증 시스템이 경영성과에 미치는 영향 분석 : 국내 의료기기 제조업을 대상으로)

  • Kim, Chung-Yeon;Ko, Sung-Seok;Han, Yong-Hee
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.41 no.1
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    • pp.11-23
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    • 2018
  • This paper investigated relationship among internal as well as external motive to receive the ISO 13485 certification, countermeasure to the certification examination, active reception/execution level of the certification, and operational as well as financial performance of the medical device related enterprises in South Korea which received and are maintaining the ISO 13485 certification. SEM (structural equation model) and related analyses using AMOS 21.0 and SPSS 21.0 have been applied to verify the hypotheses of the research. Result of the research showed that internal as well as external motive for certification positively(+) affects active reception/execution level of the certification as well as countermeasure to the certification examination. The reception/execution level of the certification also positively(+) affects on the operational as well as financial performance of the certified enterprises. However, countermeasure to the certification examination was found out to negatively(-) affects the active reception/execution level of the certification and we can interpret that relatively more countermeasure to the certification examination burdens the employees of the enterprise, causing them to be less active on the reception/execution level of the certification. This research found that an enterprise's operational/financial performance improves when an enterprise introduces the ISO 13485 certification standard spontaneously on the purpose of improving its system and the certification system is applied to the enterprise actively, not passively. This research emphasizes the need to recognize the difference of the level of active reception implication among members of an enterprise according to the motive of introduction of the certification system.

Improving Assessment of External Environment for Green Standard for Energy & Environmental Design Certification according to Climate Change (기후변화에 따른 녹색건축인증제도의 외부환경 평가항목 개선방향 연구)

  • Kim, Ji-Hyeon;Kwon, Hyuck-Sam;Kim, Jung-Gon;Song, Ok-Hee
    • Land and Housing Review
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    • v.8 no.3
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    • pp.171-180
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    • 2017
  • In 1990s, as the extreme weather events according to the global warming climate change are occurred frequently all around the world and the scale of the damage increases, the developed countries are promoting various policies for reducing greenhouse gas emissions setting the goal of greenhouse gas reduction with the level of State and local government. Especially for the greenhouse gas reduction of buildings and the inducement of eco-friendly design, the green certification system is strengthened with the assessment of energy and greenhouse management, and recently, according to the policy change of climate and energy, the certification system expanded from the buildings to the level of city and district is piloted. So this research is to understand the main contents and the assessment system of domestic green building certification system implemented in March 2013 in response to the policy change of climate and energy and to suggest the basic data for the improvement of present domestic greenhouse certification standard through the analysis of actual certification and the main case analysis of international green certification system. Recently in developed countries, in 1990s, for the reduction of building's greenhouse gas emission and the inducement of eco-friendly design, from the building of LEED, BREEAM, DGNB to the level of city and district such as LEED Neighborhood Development, BREEAM Communities, DGNB Stadtquartiere, the system is expanded and piloted. On the contrary, as for the domestic standard of green building certification system, the distribution ratio according to the assessment items in each category consists of the assessment system based on the buildings, and just the simple adjustment of some items and the improvement of weighted value are performed. Actually, as a result of selecting the 30 districts of apartment housing with the most certification performance by use among the 49 buildings certified by Institute of Land & Housing from December 2014 to July 2016 and analyzing the assessment score, the certification level is determined by the sectors of high distribution like indoor environment and energy not by the ineffective sector of external environment with low distribution so this system has a limitation to perform the practical means for the policy change of climate and energy. Thus for the national green building certification standards, the assessment system in the sector of external environment is to complemented and furthermore, reflecting domestic reality, through the introduction of certification system and the assessment system with the level of city and district, this system should be improved to meet the international certification standard.

Study on establishment of airworthiness level of safety for UAV (무인기 감항기준 안전도 설정기법 연구)

  • Choi, Joo-won
    • Journal of Aerospace System Engineering
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    • v.2 no.4
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    • pp.31-37
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    • 2008
  • To operate UAV in the civil airspace, the airworthiness of UAV system have to be proven by the civil certification system. However, it is difficult for UAV to be certified by the existing certification system because the existing certification system has been developed for the manned aircraft. So, many civil aviation authorities and research institutes are studying developing airworthiness standards for UAV certification. To develop an airworthiness standards for UAV, the airworthiness level of safety have to be established based on UAV categorization. I would like to introduce an quantitative methods for establishing airworthiness level of safety of UAV based on UAV categorization and example of Smart UAV.

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A Study for the Construction Conformity Assessment System According to the New Paradigm of Construction Management (건설관리 패러다임 전환에 따른 건설공사 품질관리 적합성평가 시스템 구축에 대한 연구)

  • Lee, Kab-Soon;Bae, Young-Ju
    • Journal of the Korea Safety Management & Science
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    • v.19 no.1
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    • pp.39-52
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    • 2017
  • The scope of this study is the construction conformity assessment system according to the new paradigm of construction management To minimize the differences between domestic and international state, construction Conformity Assessment is subdivided into system certification and product certification. For the former, WASCON(Worldwide Assessment System of Construction Quality Maturity Stage) is applied. For the latter, AQUA(Advanced Quality Assessment System) was developed and adopted to model project for demonstration. Both systems are designed to enable quantified rating, integrated into PQCS(Project Quality Certification), which is an advanced project quality certification system. The construction work observing PQCS will gain quality score on its own quality certificate(Quality mark on construction itself or facilities is also available, if needed or preferred by customers). This Quality Rating System will inspire and encourage any related parties. PQCS score would let supplier/constructor recognize how much themselves are operating effectively and efficiently, offering them the opportunity of redeeming their weaknesses.

Factor Analysis for Activation of Certification industry (GS인증산업 활성화를 위한 요인분석)

  • Kim, Shin-Pyo;Lee, Soon-Bae;Lee, Gil-Min;Kim, Jong-Sik
    • Journal of Industrial Convergence
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    • v.13 no.2
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    • pp.1-9
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    • 2015
  • This Study aims to present the guidelines for the activation of the domestic GS certification market through the assessment of the characteristics of the demands of the domestic SW companies pursuing to acquire GS certification. As the results of the factor analysis of the guidelines for the activation of the domestic GS certification market, (1) strictness of the certification standards, (2) level of satisfaction on the certification services and (3) certification effects were deduced as the specific variables. This study is highly significant in that the fact that the certification market is more effectively activated when the 3 factors, namely, strictness of the certification standards, level of satisfaction on the certification services and certification effects, have been intensively reinforced although there exist countless number of specific variables including certification system, certification cost, certification expertise and certification marketing, etc. in order to activate GS certification market has been statistically verified.

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Convergence Security Provider Self-Conformity System (융합보안 공급자 자기 적합성 제도)

  • Baik, Namkyun
    • Journal of Korea Society of Digital Industry and Information Management
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    • v.15 no.2
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    • pp.53-61
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    • 2019
  • In this paper, we propose 'a self - conformance system of convergence security provider' to provide basic data for security and reliability of convergence industrial technology, system and service. It is difficult to evaluate convergence security systems, limited to information and communication service providers, unable to check convergence security items, burden of submission documents, difficulty in measuring convergence security service level and we will summarize product and service-based requirements that can be integrated and systematically measure the level of convergence security and define renewed life cycle-based convergence security information and content security and assurance requirements. On the basis of this, each convergence security company declares conformity with the standard itself without the certification of the certification body, and introduces the provider conformity certification system which can manufacture and sell. This will enable the company to strengthen its competitiveness through timely launch and implementation of products and services and cost reduction.

Study on the stall characteristics improvement and compliance verification of the G.A. airplane (소형비행기 실속특성 향상 및 적합성검증 방안 연구)

  • Choi, Joowon;Kim, Jinsoo
    • Journal of Aerospace System Engineering
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    • v.8 no.3
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    • pp.47-54
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    • 2014
  • This is a research on the method of how to improve stall characteristics for the small general aviation airplanes to meet the FAR part 23 requirements. This research is based on the experience of certification flight tests of KC-100 airplane for Korea type certification. KAS/FAR Part 23.201/203 are the stall characteristics requirements. 23.201 requires to show the stable stalling tendency of the wings level stall and 23.203 requires to show the stable stalling tendency of stall characteristics during turning flight. In this paper, the stall characteristics requirements, improvement methods and flight test experience of KC-100 airplane for type certification.

A Study on the Airworthiness Certification of Korean Indigenously Developed Military Aircrafts (국내 개발 군용항공기 감항성 인증에 대한 연구)

  • Yoon, Heekweon;Lee, Sangchul
    • Journal of Aerospace System Engineering
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    • v.1 no.2
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    • pp.1-5
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    • 2007
  • This is a study on the effective and efficient way of airworthiness certification for Korean indigenously developed military aircrafts. Investigating the policy, process, and capability for military aircraft airworthiness certification in USA end Europe, the approach for Korean military aircraft airworthiness certification is recommended. Using FAR as basis for military airworthiness criteria is much more beneficial in initial stage of establishing airworthiness certification system. And all the available resources regardless of civil or military institutes need to be cooperated to accomplish required level of indigenous airworthiness certification capability.

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Study on Status of Barrier Free Certification & Improvement Strategies (여객자동차 터미널 이동편의시설 BF 실태 및 개선방안 연구)

  • Park, Shin-Won;Cho, Young-Tae
    • Land and Housing Review
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    • v.7 no.4
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    • pp.225-237
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    • 2016
  • This study is to investigate actual condition of passenger terminals, public facilities which are used by unspecified individuals, with high spread effect of certification system of Barrier Free introduced in 2007, evaluate possibility of the certification and prepare an effective way for certification in order to spread and settle the certification system. According to the investigation on the facilities' equipment level of 349 passenger terminals, which being nationally operated, 217 terminals could be certified and non-certified were 58. And, 29 was evaluated as the passenger terminals with high possibility to get Barrier Free certification by small scale of remodeling. The level of Barrier Free of investigated passenger terminals, according to the actual condition with certification index, were 40~55 percent. While the level of Barrier Free of internal facilities of the terminals was over 90percent, the level of sanitary facilities, information facilities, etc. fell short of 50 percents. In this study, pilot project of Barrier Free certification is proposed for enhance of passenger terminal facilities. Moreover, the selection of passenger terminals with high possibility of certification, local governments' strong will as the targets of pilot project for improvement of amenity level and Barrier Free certification and monitoring the project results are the way of the project.

A Study on Consumers' Purchasing Behavior and Perception of the Low-carbon Certificated Agricultural Products (소비자의 저탄소 인증 농산물 구매행태 및 인식에 관한 연구)

  • Lee, Choon-Soo;Yang, Hun-Min
    • Korean Journal of Organic Agriculture
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    • v.29 no.3
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    • pp.333-358
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    • 2021
  • This study investigates consumers' purchasing behavior and perception of the low-carbon certificated agricultural product. To this end, we surveyed 1,000 consumers and the main findings are as follows. First, Even after six years of national certification, it is important to promote the low-carbon certification system due to insufficient awareness and purchase experience. Second, the certificated area is small at around 5% of the area of environment-friendly agricultural products and GAP certification, and certification is concentrated on fruit trees. Third, an appropriate level of high-priced strategy can be useful considering the cost of low-carbon certification, image management of low-carbon certificated agricultural products, and quality is the most important factor for consumers to consider when purchasing fresh agricultural products. Fourth, consumers recognized that the contribution of low carbon certification in reducing greenhouse gas emissions and preserving the environment was higher than that of environment-friendly agricultural products or GAP certification. Considering that, promotional activities linked to environment-friendly agricultural products and GAP certification may be effective when promoting low-carbon certification. Finally, the Ministry of Agriculture, Food and Rural Affairs is implementing a carbon point system linked to Green Card to revitalize low carbon certification, but 25.7% of consumers are aware of it, and 8.4% have little experience in issuing it.